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ACRP Authentic ACRP-CP Exam Questions | Easy To Study and Pass Exam at first attempt & ACRP-CP: ACRP Certified Professional Exam

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ACRP Certified Professional Exam Sample Questions (Q37-Q42):

NEW QUESTION # 37
One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A. Comparing source document data to other data recorded in the same study time period.
B. Recording the date and time each data element is entered onto the source document.
C. Allowing real-time access for data review in the eCRF.
D. Recording data on source documents at the time the data are collected during the conduct of the study.

Answer: D

Explanation:
Contemporaneous data means that data entries are made at the time of the event or as soon as possible after the event occurs. This practice ensures that the recorded data accurately reflect the participant's condition and study procedures, minimizing recall bias and errors. Maintaining contemporaneous records is a fundamental requirement for ensuring the accuracy and reliability of clinical trial data.
GCP guidelines specify that data should be recorded as close to the time of the event as possible to ensure accuracy and reliability.
"Data must be contemporaneously recorded, meaning they are documented at the time of the occurrence to accurately reflect the study conduct." Objectives:
* Ensure accurate and real-time data capture.
* Maintain data integrity by minimizing recall bias.

NEW QUESTION # 38
A root cause analysis should be:

A. Validated before use in a CAPA.
B. Written by the investigator.
C. Focused on issues of non-compliance.
D. Specific to a clinical trial.

Answer: C

Explanation:
Root cause analysis (RCA) is a systematic process aimed at identifying the underlying reasons for non- compliance or errors in clinical trials. The purpose of RCA is to understand why a problem occurred so that corrective and preventive actions (CAPA) can be implemented effectively. Focusing on issues of non- compliance ensures that the study adheres to GCP and regulatory requirements.
GCP guidelines recommend performing a root cause analysis when deviations or non-compliance are identified to develop effective CAPA plans.
"Root cause analysis focuses on identifying non-compliance issues to implement corrective and preventive measures effectively." Objectives:
* Address non-compliance systematically.
* Develop effective CAPA plans.

NEW QUESTION # 39
During a multi-center, double-blind, placebo-controlled Phase III clinical trial evaluating a novel oncology drug, the following situation occurs:
An interim analysis performed by the DSMB reveals that the investigational product (IP) shows a statistically significant improvement in progression-free survival (PFS) compared to the placebo. However, a sub-group analysis indicates a higher incidence of Grade 4 hepatotoxicity in patients with pre-existing mild liver dysfunction.
The sponsor, upon reviewing the DSMB report, decides to unblind the affected sub-group to assess safety.
The trial protocol specifies that unblinding should only occur if a life-threatening situation is identified.
What is the most appropriate next step the sponsor should take?

A. Immediately unblind the entire trial to ensure patient safety.
B. Request the DSMB to conduct a full risk assessment and recommend whether the sub-group should be unblinded.
C. Submit the DSMB findings to the IRB/IEC and await their guidance before proceeding.
D. Conduct an urgent protocol amendment to include specific monitoring for hepatotoxicity and submit to the IRB/IEC.

Answer: B

Explanation:
In this situation, the correct course of action is to request the DSMB to conduct a thorough risk assessment and provide recommendations on unblinding the affected sub-group.
* Reasoning:
* The trial protocol specifies that unblinding should only occur if a life-threatening situation arises.
Since the observed hepatotoxicity, although severe, does not automatically qualify as life- threatening, it is prudent to proceed cautiously.
* Immediate unblinding of the entire trial (Option A) would compromise the study's integrity and could introduce bias.
* Submitting the DSMB findings to the IRB/IEC (Option B) without first conducting a more thorough risk assessment may delay necessary safety measures.
* Conducting a protocol amendment (Option C) without a comprehensive risk assessment may be premature.
* Role of the DSMB:
* The DSMB is responsible for evaluating safety data and making independent recommendations to protect trial participants. In this case, the DSMB should analyze the risk/benefit ratio of continuing the trial with the current protocol versus implementing safety modifications.
* Ethical Considerations:
* Protecting patient safety is paramount, but any unblinding must be justified by a clear and imminent risk. The DSMB's independent judgment is critical to making this decision without sponsor influence.
Verified Answer from Official Source:
According to GCP guidelines, any decision to unblind a study must be based on a comprehensive safety assessment, and the DSMB plays a key role in making unbiased recommendations regarding unblinding.
Exact Extract:
"Unblinding in a clinical trial should only occur when justified by critical safety concerns, as recommended by an independent data monitoring committee." Objectives:
* Maintain trial integrity while safeguarding patient safety.
* Follow protocol and regulatory requirements for unblinding.
* Ensure independent decision-making by the DSMB to avoid sponsor bias.

NEW QUESTION # 40
The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

A. Confirm subjects receive the appropriate reimbursement.
B. Assure the ads do not impinge on confidentiality agreements.
C. Safeguard the rights, safety, and well-being of all potential subjects.
D. Review the content for ethically or morally sensitive issues.

Answer: C

Explanation:
The IRB/IEC's primary responsibility when reviewing recruitment materials such as posters, fliers, social media posts, and promotional items is to ensure that these materials safeguard the rights, safety, and well- being of potential participants. This includes ensuring that the information is presented ethically, clearly, and without coercion, maintaining compliance with ethical guidelines.
GCP guidelines require that any materials used for recruitment be reviewed to ensure they do not mislead participants and that they respect their rights and well-being.
"IRB/IEC review of recruitment materials ensures that they protect participants' rights and well-being and that the content is ethically appropriate." Objectives:
* Maintain ethical standards in recruitment.
* Protect potential participants from misleading or coercive information.

NEW QUESTION # 41
Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A. Determine the quality tolerance limits for data transcription errors.
B. Identify critical processes and data during protocol development.
C. Perform a periodic review to see if the quality methods are effective and relevant.
D. Train the research coordinator on the required study assessments schedule.

Answer: B

Explanation:
The first step in establishing a robust quality management system (QMS) is to identify critical processes and data during protocol development. This step ensures that quality objectives are clear and that monitoring and quality control efforts are focused on the most significant aspects of the study. By understanding critical data points and processes early, the sponsor can design a more effective QMS to manage risks.
GCP guidelines emphasize identifying critical data and processes at the earliest stages to develop a risk-based quality management approach.
"Identification of critical data and processes at the protocol development stage is essential for designing an effective quality management system." Objectives:
* Establish quality oversight from the start.
* Implement a risk-based monitoring approach.

NEW QUESTION # 42
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Mike Taylor Mike Taylor

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